Low Prevalence Rate of Indeterminate Serological Human Immunodeficiency Virus Results among Pregnant Women from Burkina Faso, West Africa

Abstract

In sub-Saharan Africa, rapid testing for human immunodeficiency virus (HIV) is the most efficient and sometimes the only feasible way to quickly provide information about HIV status among adults and children Ն18 months of age (6,29). In contrast to enzyme immunoassays (EIAs) and Western blot assays (WBs), HIV rapid tests are relatively cheap, easy to use, and fast to perform. Most of them do not require refrigeration, sophisticated laboratory equipment, skilled technicians, and an electricity supply. Results from serum, plasma, whole-blood, urine, or saliva samples are obtained by visual reading after a few minutes. Some of the rapid tests can distinguish HIV type 1 (HIV-1) from HIV type 2 (HIV-2). They are also accurate and reliable as a result of applying a quality system approach recommended by the World Health Organization (WHO) (36). Due to their low cost and technical advantages, they have been adopted into national HIV voluntary counseling and testing (VCT) guidelines in many African countries. Their sensitivity and specificity have been studied in Kenya (12), Tanzania (22), Uganda (15), Zambia (30), South Africa (25), Cameroon (1), Central African Republic (24), Democratic Republic of Congo (19), Ghana (2), Ivory Coast (32), and Burkina Faso (23, 28).One objective for rapid HIV testing is to minimize the occurrence of indeterminate results (i.e., discordant results when using at least two different rapid tests). It is often quite difficult for HIV counselors and health care providers to disclose such indeterminate results. In the context of interventions for prevention of mother-to-child transmission (PMTCT) of HIV-1 (which can require immediate decisions, notably during labor), medical staff need to know rapidly the HIV status of the woman from the laboratory in order to provide her, or not, antiretroviral (ARV) prophylaxis (5,26,27). The prolonged delay in the decision (by performing additional tests or by retesting women 14 days later) can be inappropriate in the clinical routine since women may deliver before obtaining definitive results.The aims of this study conducted among pregnant women from Burkina Faso (West Africa) with a low risk of early HIV-1 seroconversion were (i) to determine the prevalence rates of indeterminate results by using two rapid tests in a sequential algorithm, as recommended in Burkina Faso, and (ii) to assess, using additional tests, the biological significance of indeterminate results in order to define a more rational strategy at the individual and public health levels.(This work was presented in part at the

Combining rapid diagnostic tests and dried blood spot assays for point-of-care testing of human immunodeficiency virus, hepatitis B and hepatitis C infections in Burkina Faso, West Africa

“…Hence, in low‐incidence countries such as Burkina Faso, where HIV prevalence is estimated to be between 1.0 and 1.5% , false‐positive results constitute a significant proportion of the positive results found with HIV screening tests. Previous studies performed in African pregnant women using HIV RDTs reported that >1% of the results were indeterminate . Spiking venous blood onto DBS filter cards to perform confirmatory tests may be especially interesting in such cases.…”

Potential Impact of Existing Interventions and of Antiretroviral Use in Female Sex Workers on Transmission of HIV in Burkina Faso

“…However, despite the higher prevalence predicted by our model in 2010 as compared with the demographic and health survey estimates, this is consistent with surveillance data from antenatal clinics in Bobo-Dioulasso, where prevalence was 4.2% (95% CI: 3.9 to 4.5) in 2007. 78 Second, although the model assumed more conservative efficacy estimates for the impact of ART on HIV infectivity, our results should be considered cautiously because there are little data on the efficacy of ART in high-risk populations. Instead, data on genital shedding of HIV from FSWs in this setting was used to estimate the likely efficacy of ART, but this method has not been validated; nor is it not known if low levels of HIV-1 RNA detected in women on ART represents infectious virus.…”

Measures and Metrics for Feasibility of Proof-of-Concept Studies With Human Immunodeficiency Virus Rapid Point-of-Care Technologies

“…Of the 53 studies reporting on acceptability measure, 81% (n = 43/53) documented it well and counted only acceptability of tests as a metric, but 15% of studies (n = 8/53) 21 , 28 – 34 misclassified it; they counted refusal to test as acceptability. The other 2 studies 35 , 36 combined within acceptability several processes like consent, testing, and study procedures.…”

“…One study reported on the increase in awareness of rapid tests, before and after the introduction of the tests. 28 …”